Watson aims for August launch of EC

The maker of the just-approved Next Choice emergency contraceptive, a generic of Teva's Plan B (levonorgestrel), applies to make the drug available for nonprescription sale upon the expiration of Teva's market exclusivity Aug. 24. A spokeswoman said June 29 that Watson Pharmaceuticals is confident FDA will approve the Next Choice nonprescription application, but does not know whether the decision will come before Plan B loses exclusivity. FDA likely will apply to non-Rx levonorgestrel generics the same age restriction on pharmacy-only sales it imposed on Plan B (1"The Tan Sheet" June 29, 2009). Watson reserves the right to later seek universal OTC sales status, the spokeswoman said

The maker of the just-approved Next Choice emergency contraceptive, a generic of Teva's Plan B (levonorgestrel), applies to make the drug available for nonprescription sale upon the expiration of Teva's market exclusivity Aug. 24. A spokeswoman said June 29 that Watson Pharmaceuticals is confident FDA will approve the Next Choice nonprescription application, but does not know whether the decision will come before Plan B loses exclusivity. FDA likely will apply to non-Rx levonorgestrel generics the same age restriction on pharmacy-only sales it imposed on Plan B (¹ (Also see "Generic Rx Plan B Approval Points To Possible OTC Equivalents In Near Future" - Pink Sheet, 29 Jun, 2009.)). Watson reserves the right to later seek universal OTC sales status, the spokeswoman said.